Lung Volume Reduction Devices, Methods, and Systems

ABSTRACT

The invention provides improved medical devices, therapeutic treatment systems, and treatment methods for treatment of the lung. A lung volume reduction system includes an implantable device having an elongate body that is sized and shaped for delivery via the airway system to a lung airway of a patient. The implant is inserted and positioned while the implant is in a delivery configuration, and is reconfigured to a deployed configuration so as to locally compress adjacent tissue of the lung, with portions of the elongate body generally moving laterally within the airway so as to laterally compress lung tissue. A plurality of such implants will often be used to treat a lung of a patient.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 13/618,822 filed Sep. 14, 2012 (Allowed); which is aContinuation of U.S. patent application Ser. No. 13/418,534 filed Mar.13, 2012 (Allowed); which is a Continuation of U.S. patent applicationSer. No. 12/209,662 filed Sep. 12, 2008 (now U.S. Pat. No. 8,157,823);which is a Continuation-in-Part of U.S. patent application Ser. No.12/167,167 filed on Jul. 2, 2008 (now U.S. Pat. No. 8,282,660); which isa Continuation application of PCT Patent Appln. No. PCT/US2007/006339filed internationally on Mar. 13, 2007; which claims the benefit ofpriority to U.S. Provisional Patent Appln. No. 60/884,804 filed Jan. 12,2007 and U.S. Provisional Patent Appln. No. 60/885,305 filed Jan. 17,2007 and which is a Continuation-in-Part of U.S. patent application Ser.No. 11/422,047 filed Jun. 2, 2006 (now U.S. Pat. No. 8,157,837)—whichclaims the benefit of priority under 35 U.S.C. §109(e) of U.S.Provisional Appln. No. 60/743,471 filed on Mar. 13, 2006. All of whichare incorporated herein by reference in their entirety, for allpurposes.

This application is generally related to co-assigned and concurrentlyfiled U.S. patent application Ser. No. 12/209,631 (now U.S. Pat. No.8,142,455), entitled Delivery of Minimally Invasive Lung VolumeReduction Devices; 61/096,550 entitled Enhanced Efficacy Lung VolumeReduction; and 61/096,559 entitled Elongated Lung Volume ReductionDevices, Methods, and Systems, each of which are incorporated herein byreference in their entirety for all purposes.

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Devices, systems and methods are described for treating lungs. Thedevices, systems and methods improve the quality of life and restorelung function for patients suffering from emphysema. The systems consistof an implant and a delivery catheter that can be advanced throughtortuous anatomy and actuated to retain a pre-determined shape andrigidity. The actuated implant modifies the shape of the airways andlocally compresses lung parenchyma to cause volume reduction and therebytensions the lung parenchyma to restore elastic recoil. Systems anddevices are also included that deploy and actuate the implantabledevices, as well as systems and devices designed for recapture of theimplanted device.

2. Background of the Invention

Current medical literature describes emphysema as a chronic (long-term)lung disease that can get worse over time. It's usually caused bysmoking. Having emphysema means some of the air sacs in your lungs aredamaged, making it hard to breathe. Some reports indicate that emphysemais the fourth largest cause of mortality in the U.S., affecting anestimated 16-30 million U.S. citizens. Each year approximately 100,000sufferers die of the disease. Smoking has been identified as a majorcause, but with ever increasing air pollution and other environmentalfactors that negatively affect pulmonary patients; the number of peopleaffected by emphysema is on the rise.

A currently available solution for patients suffering from emphysema isa surgical procedure called Lung Volume Reduction (LVR) surgery wherebydiseased lung is resected and the volume of the lung is reduced. Thisallows healthier lung tissue to expand into the volume previouslyoccupied by the diseased tissue and allows the diaphragm to recover.High mortality and morbidity may be associated with this invasiveprocedure. Several minimally invasive investigational therapies existthat aim at improving the quality of life and restoring lung functionfor patients suffering from emphysema. These potential therapies includemechanical devices and biological treatments. The Zephyr™ device byEmphasys (Redwood City Calif.) and the IBV™ device by Spiration (RedmondWash.) are mechanical one way valve devices. The underlying theorybehind these devices is to achieve absorptive atelectasis by preventingair from entering diseased portion of the lung, while allowing air andmucous to pass through the device out of the diseased regions.

The Watanabe spigot is another mechanical device that completelyoccludes the airway, thereby preventing air from entering and exitingthe lung. Collateral ventilation (interlobar and intralobar-porous flowpaths that prevent complete occlusion) prevents atelectasis and this isshown in the published Emphasys VENT clinical trial data, whereapproximately ⅓ or fewer of the patients actually achieve measurableatelectasis. The lack of atelectasis or lung volume reductiondrastically reduces the effectiveness of such devices. Other mechanicaldevices include means of deploying anchors into airways and physicallydeforming airways by drawing the anchors together via cables.

Biological treatments utilize tissue engineering aimed at causingscarring at specific locations. Unfortunately, it can be difficult tocontrol the scarring and to prevent uncontrolled proliferation ofscarring.

SUMMARY OF THE INVENTION

The present invention generally provides improved medical devices,therapeutic treatment systems, and treatment methods, particularly fortreatment of the lung. An exemplary lung volume reduction systemincludes an implantable device having an elongate body that is sized andshaped for delivery via the airway system to a lung airway of a patient.The implant is inserted and positioned while the implant is in adelivery configuration, and is reconfigured to a deployed configurationso as to locally compress adjacent tissue of the lung. Duringreconfiguring or deployment of the implant, portions of the elongatebody generally move laterally within the airway so as to laterallycompress lung tissue, ideally with the diseased lung tissue beingcompressed between two or more axially separated portions of theelongate body, the elongate body often being resiliently biased so as tobend the lung airway. A plurality of such implants will often be used totreat a lung of a patient. Methods of compressing lung tissue are alsoprovided, with the lung tissue often being compressed between airwayaxial regions from within the airway axial regions, typically usingelongate structures extending along those axial regions and often bybending an elongate body inserted of a device inserted into the airwaysystem in a delivery configuration that bends into a deployedconfiguration, thereby bending the airway system.

An aspect of the invention provides a method for treating a lung of apatient. The lung includes a first airway axial region and a secondairway axial region. A lung tissue volume is compressed by urging thefirst airway axial region laterally toward the second airway axialregion using an implant system extending into the first and secondairway axial regions.

Each airway axial region extends along an associated axial regioncentral axis, and the airway axial regions may each comprise elongatelengths of the airway system (such that they are significantly longeralong the airway axis than they are wide). The compressed volume of lungtissue is often disposed at least in part between the first airway axialregion and the second airway axial region. The volume of lung tissue iscompressed by laterally urging the airway axial regions together usingelongate implant portions extending axially within the airway axialregions. For example, the implant system may comprise an elongate bodyhaving a proximal portion and a distal portion. The distal portion ofthe elongate body often passes through the first airway axial region andengages the second airway axial region, as the first and second airwayaxial regions are coupled together axially. The proximal portion of theelongate body engages the first airway axial region. The lung tissuevolume may be compressed by bending of the elongate body between theproximal portion and the distal portion. The bending of the elongatebody within the airway axial regions urges a bearing surface of theelongate body laterally against an airway lumen surface so as to imposea bend in the airway system between the airway axial regions. Thebearing surface may not penetrate through the airway surface duringdeployment of the elongate body. A portion of the implant, particularlynear an end of the elongate body, may over time penetrate into and/orthrough a engaged airway lumen wall. Efficacy of the implant may, atleast in part, be independent of collateral flow so that the implant maycontinue to provide therapeutic benefits despite such penetration.

The implant may benefit from a three-dimensional or non-planar geometryso as to provide a desired level of compression on a desired volume oflung tissue. For example, a surface can generally be defined between thefirst and second airway region axes. A similar surface can be definedbetween local axes of the elongate body portions of the implant.Regardless, in many embodiments, a third airway axial region may beurged toward the surface from within the third airway axial region sothat the compressed volume of lung tissue is disposed at least in partbetween the surface and the third airway axial region. In someembodiments, a fourth airway axial region may be urged toward the first,second, and third airway axial regions, the compressed lung tissuevolume being disposed therebetween, optionally with a continuouselongate body that extends through each of the airway axial regions.

In many embodiments, a third airway axial region is urged laterallytoward a fourth airway axial region from within third and fourth airwayaxial regions, respectively. These airway axial regions may bemanipulated by additional portions of the same elongate body, or byusing a separate elongate body implanted within the lung.Advantageously, the compressed volume of lung tissue may be sufficientlylarge and may be compressed sufficiently to increase tension in anuncompressed volume of the lung such that lung function of the lung isincreased.

Another aspect of the invention provides a method for treating a lung ofa patient. The lung includes an airway system. The method comprisesincreasing tension within a portion of a lung by pushing againstelongate luminal surface regions of the airway system from within theairway system sufficiently to compress another portion of the lung.

Another aspect of the invention provides an implant for treating a lungof a patient. The lung includes a first airway axial region and a secondairway axial region. The implant comprises a first elongate body portionhaving a first local axis and a second elongate body portion having asecond local axis. The elongate body portions are coupled together sothat the implant is deployable from a first configuration to a secondconfiguration when the first elongate body portion extends axially alongthe first airway axial region and the second elongate body portionextends axially along the second airway axial region. The elongate bodyportions in the second configuration compress a lung tissue volumelaterally between the first airway axial region and the second airwayaxial region.

An intermediate elongate body portion may couple the first elongate bodyportion to the second elongate body portion Hence, these elongate bodyportions may be included within a continuous elongate body. The elongatebody can be biased to bend from the first configuration to the secondconfiguration so as to compress the lung tissue volume. Advantageously,compression can be effected atraumatically by urging an elongate bearingsurface of the elongate body laterally against an airway lumen surfaceso as to impose a bend in the airway system between (and optionallyalong) the airway axial regions. The bearing surface need not becontinuous, and may have an overall size sufficient to inhibitpenetration through the airway surface during deployment of the elongatebody. A third elongate body portion may be coupled to the first andsecond body portions. Analogous to the description above regardingthree-dimensional compression of the lung tissue, a surface can bedefined between the first and second local axes when the implant is inthe second configuration. The implant in the second configuration isconfigured to urge a third airway axial region toward the surface fromwithin the third airway axial region so that the compressed volume oflung tissue is disposed at least in part between the surface and thethird airway axial region. In some embodiments, the implant comprises afourth elongate body portion coupled to the third body portion so as tourge a fourth airway axial region toward the first, second, and thirdairway axial regions when the implant is in the second configuration.The compressed lung tissue volume is disposed therebetween, with some orall of the remaining tissue of the lung thereby gaining therapeuticallybeneficial tension.

The compressed volume of lung tissue may be sufficiently large and maybe compressed sufficiently to increase tension in an uncompressed volumeof the lung such that lung function of the lung is increased.

Another aspect of the invention provides a lung volume reduction systemcomprising an implantable device adapted to be delivered to a lungairway of a patient in a delivery configuration and to change to adeployed configuration to bend the lung airway. The system has adelivery configuration that is resiliently bendable into a plurality ofshapes. The system can have a deployed configuration that has a rigidshape. Additionally, the system may be elastically strained into adeliverable shape whereby elastic recoil allows it to recover back toits manufactured shape that provides a load on lung tissue. Furthershapes include: c-shape; S-shape; and Spiral, baseball seam shape toname a few.

The system can further be adapted to comprise an actuator adapted to beoperated from outside the patient to change the implantable device fromthe delivery configuration to the deployed configuration. The actuatorcomprises an actuation element connected to a distal end of theimplantable device and adapted to be moved proximally to bend thedevice. As will be appreciated by those skilled in the art, the distalend includes the front end of the device and can include, for example,from the mid-point along the length to the end furthest away from theuser.

In some embodiments, the system can further be adapted to comprise alock adapted to lock the device in the deployed configuration. In someembodiments, the lock comprises a ratchet. In other embodiments, thelock can be unlocked for retrieval. The system can further comprise aconnector adapted to connect the implantable device to the actuator andto disconnect the device from the actuator after actuation. Theconnector may be used to connect two or more devices together. Thedevice can be configured to comprise a member having a plurality ofnotches adapted to permit the device to bend more easily in onedirection than in another. In some embodiments, the device can furtherbe adapted to self-actuate from the delivery configuration to thedeployed configuration. The devices of the invention can be comprised ofshape memory material. Suitable shape memory material are known in theart and include the nickel-titanium alloy Nitinol. In some embodiments aplurality of shape memory elements can be configured to form a flexibleovertube. In other embodiments, the device comprises a plurality ofasymmetric segments and a connecting element adapted to connect thesegments. In still other embodiments, the device is adapted to bedelivered through a working channel of a bronchoscope. In still otherembodiments, the device is adapted to be delivered from a loadingcartridge through a catheter that is adapted to fit through a workingchannel of a bronchoscope. The system may include a guide wire forsteering to specific bronchi, a wire steering handle to assist withgrasping the wire to rotate it, a dilator to provide a smooth transitionfrom the wire to a delivery catheter and a loading cartridge to containthe implant system in a deliverable condition. The device can further beadapted to provide an anchor to anchor the device within the airway. Instill other embodiments, the system further comprises a delivery tooladapted to deliver the device to a treatment site in the airway. In yetother embodiments, the system further comprises a retrieval tool adaptedto retrieve the device from the airway after delivery. The retrievaldevice can further be adapted to unlock the device from the deployedconfiguration. As will be appreciated by those skilled in the art, thedevice can be configured to have a fixed length or a variable length.

A method of bending a lung airway of a patient is also provided. Themethod comprising inserting a device into the airway in a deliveryconfiguration and bending the device into a deployed configuration,thereby bending the airway. In some embodiments of the method, thebending step comprises operating an actuator outside the patient, theactuator being operatively connected to the device. The method furthercomprises locking the device into the deployed configuration. The methodcan also comprise unlocking the device to permit it to return to thedelivery configuration. In yet other embodiments, the method can includedisconnecting the actuator from the device. In some instances, thedevice comprises a plurality of asymmetric segments, inserting comprisesdelivering the plurality of asymmetric segment to the airway. In stillother embodiments, the bending comprises rotating at least oneasymmetric segment with respect to at least another asymmetric segment.In some instances, the device comprises shape memory material, bendingcomprises permitting the device to bend itself. The method can alsofurther comprise the step of delivering an overtube and subsequentlydelivering a shape memory element to the overtube. Depending upon thedesired result, the bending can comprise bending the device into asubstantially C shape; bending the device into a substantially S shape;or bending the device into a substantially spiral shape. Additionally,the inserting step can further comprise delivering the device through aworking channel of a bronchoscope. In yet other embodiments, the devicecan be elastically strained into a deliverable shape, advanced throughand out the end of a bronchoscope whereby elastic recoil drives thesystem, to recover back to its original manufactured shape. Finally, themethod can further comprise the step of retrieving the device from theairway.

The design of the device facilitates strain relief on both ends of thedevice. Further the ends of the device in either the delivery ordeployed state are more resilient.

The implant length can range from, for example, 2 cm to 10 cm.Typically, the length is 5 cm. The diameter of the device can range from1.00 mm to 3.0 mm, preferably 2.4 mm. The device is used with a catheterwhich has a working length of 60 cm to 200 cm, preferably 90 cm.

Suitable materials for use in constructing the implant, delivery orretrieval systems include materials selected from: metals (stainlesssteel, nickel-titanium alloy (Nitinol), titanium); polymers (durable andbioabsorbable); ultra high molecular weight polyethylene (UHMWPE),polycarbonate, silicone, urethane, Teflon® (available from DuPont),fluoropolymers, Poly (d, l-lactic-co-glycolic acid), poly(glycolic acidcaprolactone), [rho]oly(lactide co-glycolides), as well as any othermaterial that would be considered suitable by a person of skill in theart. Other materials include polymers (nylon, Pebax®,polyetheretherketone (PEEK), polycarbonate, Acrylonitrile ButadieneStyrene (ABS), high density polyethylene, low density polyethylene,polypropylene, polyimide, urethane, polyethylene, and terephthalate), aswell as any other material that would be considered suitable by a personof skill in the art. One or more materials can be employed in any of theembodiments described.

In one embodiment, the device is constructed from a metallic orpolymeric tube with slots separated by specific distances that allowpreferential bending of the tube where the slots are oriented. Inanother embodiment, the implant is composed of short segments ofmetallic or polymeric tubes or cylinders.

Aspects of the invention also include devices adapted to deliver and/orretrieve the implant. The device can be configured to pull or push theactuation device; lock the device in a particular configuration; unlockthe device; maintain the device at a temperature that facilitatesimplantation; manipulates the proximal end of the device to facilitateretrieval; and/or controls the torque on the device.

The delivery catheter construction includes a stainless steel hypotube,stainless steel tight-pitch coil, polymeric tube (polyimide, Nylon,Pebax® (available from Ato Chimie), Teflon®, fluoropolymers) withstainless steel reinforcement (braided, axial).

In operation the devices of the invention are minimally invasive and canbe used with a bronchoscope procedure. There is no incision, and noviolation of the pleural space. Collateral ventilation does not affectthe effectiveness. The devices can be used for homogeneous andheterogeneous emphysema.

In yet another embodiment of the invention, the lung volume reductionsystem comprises an implantable device that imparts bending force onlung tissue. The lung volume reduction system can further be adapted andconfigured to comprise an implantable spring element that impartsbending force on lung tissue. In yet another embodiment of theinvention, a lung volume reduction system is adapted and configured tocomprise an implantable spring element that can be constrained into ashape that can be delivered to a lung airway and unconstrained to allowthe element to impart bending force on the airway to cause the airway tobe bent.

Embodiments of the lung volume reduction system can be adapted toprovide an implant that is constrained in a first configuration to arelatively straighter delivery configuration and allowed to recover insitu to a second configuration that is less straight configuration.Devices and implants can be made, at least partially, of spring materialthat will fully recover after having been strained at least 1%, suitablematerial includes a metal, such as metals comprising Nickel andTitanium. In some embodiments, the implant of the lung volume reductionsystem is cooled below body temperature in the delivered configuration.In such an embodiment, the cooling system can be controlled by atemperature sensing feedback loop and a feedback signal can be providedby a temperature transducer in the system. The device can be configuredto have an Af temperature adjusted to 37 degrees Celsius or colder.Additionally, at least a portion of the metal of the device can betransformed to the martensite phase in the delivery configuration and/orcan be in an austenite phase condition in the deployed configuration.

In another embodiment of the invention, a lung volume reduction systemcomprising an implantable device that is configured to be deliverableinto a patient's lung and configured to be reshaped to make the lungtissue that is in contact with the device more curved. In someembodiments, The device is configured to be reshaped to a permanentsecond configuration. Additionally, or alternatively, the device can beadapted and configured to have a first shape and is configured to bestrained elastically to a deliverable shape. Additionally, in someembodiments, the implantable device has a first shape and is adapted tobe elastically constrained by a delivery device to a deliverableconfiguration whereby removal of the delivery device allows the implantto recoil and be reshaped closer to its first shape. In still otherembodiments, the tissue that is in contact with the device is that ofblood vessel, airway, lung dissection fissure or a combination of these.The delivered device can be reshaped into a shape that is shorter inlength than the deliverable implant configuration. Additionally, theimplant can be adapted and configured to provide a distal end and aproximal end and the distance between the two ends is reduced when theimplant is reshaped. Further, the implant can be configured to occupyless than the entire lumen cross section area of a lung airway; lessthan the entire lumen cross section area of a blood vessel; and/or havea deliverable shape that fits within a cylindrical space that is 18 mmin diameter or smaller. In some embodiments, the surface area of theimplant that comes into contact with tissue is larger than 1.0⁻⁶ squareinches per linear inch of length of the implant. In other embodiments,the implant is coated with material that reduces the rate of woundhealing, tissue remodeling, inflammation, generation of granular tissueor a combination of these. In still other embodiments, the reshapedimplant is adapted and configured to lie within a single plane.Additionally, the reshaped implant can take on a variety of shapes,including, for example, the shape of a C, the shape of an S, or anyother suitable shape. In still other embodiments, the reshaped implantis adapted and configured to lie within more than a single plane. Inmultiplanar embodiments, the reshaped implant is adapted and configuredto take on a variety of shapes, including, for example, the shape of abaseball seam, or the shape of a coil. In some embodiments, the reshapedimplant has more than one radius of curvature. Additionally, systems areprovided wherein more than one implant is delivered and reshaped. Insuch systems, the devices can be delivered to separate locations.Alternatively, the devices can be coupled, either before or afterdelivery. Additionally, the implants can be deployed to partially occupya common region in the lung. In still further embodiments, the lungvolume reduction system can provide implantable devices made of aresiliently bendable material. The system can further be adapted tocomprise an actuator adapted to be operated from outside the patient toreshape the implant. Suitable mechanisms for actuating the deviceinclude, catheters. Additionally, the catheter can be further adaptedand configured to constrain the implant in a deliverable configuration.In some embodiments, the system further comprises a pusher adapted todeliver the implant into a patient's lung. Additionally, the implant canbe adapted and configured to have blunt distal and proximal ends, suchas with the use of balls positioned thereon. Additionally, a centralwire can be provided that spans the length of the device. A pusher canbe provided that is releasably coupled to the device.

In another embodiment, the system provides a recapture device adaptedand configured to remove the implant from a patient's lungs. Therecapture device can be adapted to couple at an end of the device.Additionally, the recapture device can be configured to operate within acatheter or bronchoscope working channel lumen. A resilient wire canalso be provided to guide a delivery catheter. In still otherembodiments, the system further comprises a resilient dilator devicethat fits in the catheter lumen. The dilator device can be furtheradapted and configured to provide a lumen that accommodates a resilientwire. In at least some embodiments, the lung volume reduction systemimplant has an arc length that remains constant.

In yet another embodiment of the invention, a lung volume reductiondevice is provided that comprises an elongate body adapted to beinserted into a lumen adjacent lung tissue, the device having a deliveryconfiguration and a deployed configuration more curved than the deliveryconfiguration. In some embodiments, the elongate body is more rigid inthe deployment configuration than in the delivery configuration. Instill other embodiments, at least a portion of the elongate bodycomprises a rigid arc when in the deployment configuration havingrigidity greater than that of lung tissue. In some embodiments, therigid arc extends from a point in a proximal half of the device to apoint in the distal half of the device. In still other embodiments, theelongate body comprises a plurality of rigid arcs when in the deploymentconfiguration. The plurality of rigid arcs can also be positioned suchthat the arcs are not at the proximal or distal ends of the elongatebody.

In another embodiment of the invention, a lung volume reduction systemis provided comprising an implantable device that is configured to bedeliverable into a patient's lung and configured to reshape lung tissuewhile allowing fluid to flow both directions past the implant.

In still another embodiment of the invention, a lung volume reductionsystem is provided comprising an implantable device that is configuredto be deliverable into a patient's lung configured to be reshaped to ashape that is not axi-symmetric to bend lung tissue.

According to a method of the invention, a method of reducing a patient'slung volume is provided comprising: inserting a lung volume reductiondevice into a patient lumen, such as a lung airway, adjacent lung tissuein a delivery configuration, the device comprising an elongate body; andmoving the elongate body from the delivery configuration to a deploymentconfiguration more curved than the delivery configuration. The step ofmoving can further comprise making at least a portion of the elongatebody more rigid. In another embodiment, the step of moving can compriseforming a rigid arc in the elongate body, the rigid arc having arigidity greater than that of the lung tissue. In yet anotherembodiment, the step of moving can further comprise forming a pluralityof rigid arcs in the elongate body. In still another embodiment, thestep of moving can further comprise forming the plurality of rigid arcsaway from a proximal end or a distal end of the elongate body.

Pursuant to another method of the invention, a method of bending a lungairway of a patient is provided comprising inserting a device into theairway in a delivery configuration and bending the device into adeployed configuration to reduce the radius of curvature of at least aportion the airway.

Still another method of the invention provides a method of bending alung airway of a patient comprising inserting an implantable device intothe airway in a delivery configuration and bending the device into adeployed configuration to reduce the radius of curvature of at least aportion the airway. In an embodiment, the step of bending can furthercomprise operating an actuator outside the patient, the actuator beingoperatively connected to the device. In yet another embodiment, the stepof bending further comprising locking the device into the deployedconfiguration. In still another embodiment, the step of bending furthercomprises unlocking the device to permit it to return to the deliveryconfiguration. Additionally, in some embodiments, the step of bendingcan further comprise disconnecting the actuator from the device.Suitable devices for the methods of the invention include devices thatcomprise a plurality of asymmetric segments, inserting comprisesdelivering the plurality of asymmetric segments to the airway as well asdevices comprising shape memory material. Additionally, the step ofbending can further comprise rotating at least one asymmetric segmentwith respect to at least another asymmetric segment. An additional stepof some embodiments of the method can further comprise delivering acatheter and delivering a shape memory element through the catheter.After delivery of the device, according to the methods provided, thedevice can then bend into a substantially C shape, S shape, spiralshape, coil shape of one or more radiuses, as well as any shape that iswithin one or more planes. In an additional embodiment of the method,the step of inserting further comprises delivering the device through aworking channel of a bronchoscope. In yet another step of the method,the method further comprises retrieving the device from the airway.Embodiments of the method can further provide the step of providingstrain relief to an end of the device during deployment. The deliveryconfiguration of the device can be achieved by transforming metal to amartensite phase or by cooling the implant, such as by deliveringliquids or gas. Cooled liquids or gases can be at delivered attemperatures that are at or below body temperature, are 37 degreesCelsius or lower in temperature, or at or below zero degrees Celsius. Insome methods of the invention, the implant and surrounding tissues arecooled below zero degrees Celsius, or at or below minus fifteen degreesCelsius.

In yet another method of the invention, a method of reducing lung volumeby bending a lung airway of a patient is provided comprising insertingan implantable device into the airway in a delivery configuration andbending the device into a deployed configuration to change the radius ofcurvature of at least a portion of the airway.

In another method of the invention, a method is provided for reducinglung volume in a patient comprising inserting a device into an airwayand causing bending of the airway. The method can further include thestep of inserting a second device into a second airway; connecting thefirst and second devices to each other; bending the first device to athe first device to a deployed condition to bend or deform the airway ata first location; and bending the second device to a deployed conditionto bend the airway at a second location. Additionally, the method caninclude connecting two or more devices, such as connecting the devicesto a common airway. An additional step of the method can includeapplying pressure on the junction where the airways join. Still anotherstep of the method can include connecting bending elements that areindividually placed into one or more airways. Yet another step caninclude bending one or more bending elements that are placed in one ormore airways. An additional step includes configuring the device to makethe airway conform to the shape of the implant in a deployed condition.

In another embodiment, the invention provides a method for treating alung of a patient. The lung including an airway system, and the methodcomprises deploying an implant into an axial region of the airway havinga first end and a second end. The implant is deployed so that a proximalend of the implant engages the first end of the axial region, so that adistal end of the implant engages the second end of the axial region,and so that the implant bends the airway between the first end of theaxial region and the second end of the axial region. Optionally, theproximal end of the implant, the distal end of the implant, and theimplant between the proximal and distal ends press laterally against theairway so as to compress adjacent lung tissue from within the airwaysystem.

In yet another aspect, the invention provides an implant for treating alung of a patient. The lung includes an airway system, and the implantcomprises an elongate body having a proximal end and a distal end. Theimplant has an insertion configuration suitable for insertion of theimplant into an axial region of the airway so that a proximal end of theimplant is adjacent the first end of the axial region and so that adistal end of the implant is adjacent the second end of the axialregion, wherein the inserted implant is reconfigurable to a deployedconfiguration imposing a bend in the airway between the first end of theaxial region and the second end of the axial region.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentinvention will be obtained by reference to the attached documents thatset forth illustrative embodiments, in which the principles of theinvention are utilized, and the accompanying drawings of which:

FIGS. 1A-C illustrates the anatomy of the respiratory system;

FIGS. 2A-D illustrate a bronchoscope;

FIG. 3 illustrates a bronchoscope in combination with a delivery devicefor a lung volume reduction device according to the invention;

FIGS. 4A-F illustrate a lung volume reduction device according to anaspect of the invention;

FIGS. 5A-B illustrate a lung volume reduction device according toanother aspect of the invention;

FIGS. 6A-D illustrate a lung volume reduction device according toanother aspect of the invention;

FIG. 7 illustrates a lung volume reduction device according to anotheraspect of the invention;

FIG. 8 illustrates a lung volume reduction device encased in a sheath;

FIGS. 9A-D illustrate a lung volume reduction device according toanother aspect of the invention;

FIGS. 10A-B illustrate segments suitable for use in configuring a lungvolume reduction device according to an aspect of the invention;

FIGS. 11A-F illustrate a plurality of individual wires formed of shapememory material that can be deployed to form a lung volume reductiondevice and a delivery device;

FIG. 12 illustrates a lock feature suitable for use at a proximal end ofa lung volume reduction device;

FIGS. 13A-B illustrate a stopper adapted to hold tension on a lungvolume reduction device;

FIGS. 14A-C illustrates a self locking mechanism suitable for use withthe lung volume reduction devices of the invention;

FIGS. 15A-D illustrate a decoupler system;

FIG. 16A-C illustrates a decoupling system;

FIGS. 17A-B depict a mechanism for decoupling the delivery device from alung volume reduction device;

FIG. 18 illustrates another mechanism suitable for use in decoupling thedelivery device from a lung volume reduction device;

FIGS. 19A-B illustrate yet another embodiment of a decoupling system;

FIGS. 20A-E illustrate a hitch pin configuration useful in decouplingthe delivery device;

FIG. 21 illustrates an activation mechanism suitable for use with thedevices of the invention;

FIG. 22 illustrates an alternative mechanism for proximally controllingthe deployment of the device;

FIG. 23 illustrates a spur gear suitable for use with control mechanismsof the invention;

FIG. 24 illustrates a proximal control device for actuating an implant;

FIG. 25 illustrates another proximal control device and deliverycatheter system for actuating an implant while maintaining a desiredtemperature at a distal end;

FIG. 26 illustrates yet another proximal control device for use inrecapture of an implanted device;

FIGS. 27A-B illustrates an alternative embodiment of a retrieval device;

FIGS. 28A-B illustrate device components adapted to engage each other;

FIGS. 29A-C illustrate another retrieval mechanism;

FIGS. 30A-B illustrate a retrieval device comprising a snare wire;

FIGS. 31A-D illustrates devices in a variety of deployed conditions;

FIG. 32 illustrates a lung volume reduction device in combination with adelivery catheter;

FIGS. 33A-C illustrate a variety of device configurations withatraumatic tips;

FIGS. 34A-B illustrate a withdrawal system having a blade to separatethe device from the surrounding tissue;

FIGS. 35A-C illustrate a device implanted within the lungs;

FIG. 36A-B illustrate method steps for implanting the device;

FIG. 37 illustrates a device configuration;

FIG. 38 illustrates a device in a loading cartridge;

FIG. 39 illustrates a long device configuration;

FIG. 40 illustrates a device configuration with a wire support frame;

FIG. 41 illustrates a device configuration with a covering;

FIG. 42 illustrates a device configuration with a perforated covering;

FIG. 43 illustrates a device configuration with an attached wire supportframe;

FIG. 44 illustrates a device configuration with an attached frame andcovering;

FIG. 45 illustrates a device configuration that is coupled to a seconddevice;

FIG. 46 illustrates a device configuration in a coil shape;

FIG. 47 illustrates a length change from delivery to deployed;

FIG. 48 illustrates a system with bronchoscope, catheter, dilator, wireand wire steering handle;

FIG. 49 illustrates a system in an airway with device ready to deliver;

FIG. 50 illustrates a system in an airway delivering the device;

FIG. 51 illustrates a system in an airway with the device delivered;

FIGS. 52A-B illustrate bending of the airway and compression of lungtissue induced by the delivery of the device; and

FIGS. 53A-C illustrate lateral compression of tissue between portions ofthe deployed device.

DETAILED DESCRIPTION OF THE INVENTION

By way of background and to provide context for the invention, FIG. 1Aillustrates the respiratory system 10 located primarily within athoracic cavity 11. This description of anatomy and physiology isprovided in order to facilitate an understanding of the invention.Persons of skill in the art, will appreciate that the scope and natureof the invention is not limited by the anatomy discussion provided.Further, it will be appreciated there can be variations in anatomicalcharacteristics of an individual, as a result of a variety of factors,which are not described herein. The respiratory system 10 includes thetrachea 12, which brings air from the nose 8 or mouth 9 into the rightprimary bronchus 14 and the left primary bronchus 16. From the rightprimary bronchus 14 the air enters the right lung 18; from the leftprimary bronchus 16 the air enters the left lung 20. The right lung 18and the left lung 20, together comprise the lungs 19. The left lung 20is comprised of only two lobes while the right lung 18 is comprised ofthree lobes, in part to provide space for the heart typically located inthe left side of the thoracic cavity 11, also referred to as the chestcavity.

As shown in more detail in FIG. 1B, the primary bronchus, e.g. leftprimary bronchus 16, that leads into the lung, e.g. left lung 20,branches into secondary bronchus 22, and then further into tertiarybronchus 24, and still further into bronchioles 26, the terminalbronchiole 28 and finally the alveoli 30. The pleural cavity 38 is thespace between the lungs and the chest wall. The pleural cavity 38protects the lungs 19 and allows the lungs to move during breathing. Asshown in FIG. 1C, the pleura 40 defines the pleural cavity 38 andconsists of two layers, the visceral pleurae 42 and the parietal pleurae44, with a thin layer of pleural fluid therebetween. The space occupiedby the pleural fluid is referred to as the pleural space 46. Each of thetwo pleurae layers 42, 44, are comprised of very porous mesenchymalserous membranes through which small amounts of interstitial fluidtransude continually into the pleural space 46. The total amount offluid in the pleural space 46 is typically slight. Under normalconditions, excess fluid is typically pumped out of the pleural space 46by the lymphatic vessels.

The lungs 19 are described in current literature an elastic structurethat float within the thoracic cavity 11. The thin layer of pleuralfluid that surrounds the lungs 19 lubricates the movement of the lungswithin the thoracic cavity 11. Suction of excess fluid from the pleuralspace 46 into the lymphatic channels maintains a slight suction betweenthe visceral pleural surface of the lung pleura 42 and the parietalpleural surface of the thoracic cavity 44. This slight suction creates anegative pressure that keeps the lungs 19 inflated and floating withinthe thoracic cavity 11. Without the negative pressure, the lungs 19collapse like a balloon and expel air through the trachea 12. Thus, thenatural process of breathing out is almost entirely passive because ofthe elastic recoil of the lungs 19 and chest cage structures. As aresult of this physiological arrangement, when the pleura 42, 44 isbreached, the negative pressure that keeps the lungs 19 in a suspendedcondition disappears and the lungs 19 collapse from the elastic recoileffect.

When fully expanded, the lungs 19 completely fill the pleural cavity 38and the parietal pleurae 44 and visceral pleurae 42 come into contact.During the process of expansion and contraction with the inhaling andexhaling of air, the lungs 19 slide back and forth within the pleuralcavity 38. The movement within the pleural cavity 38 is facilitated bythe thin layer of mucoid fluid that lies in the pleural space 46 betweenthe parietal pleurae 44 and visceral pleurae 42. As discussed above,when the air sacs in the lungs are damaged 32, such as is the case withemphysema, it is hard to breathe. Thus, isolating the damaged air sacsto improve the elastic structure of the lung improves breathing.

A conventional flexible bronchoscope is described in U.S. Pat. No.4,880,015 to Nierman for Biopsy Forceps. As shown in FIGS. 2A-D,bronchoscope 50 can be configured to be of any suitable length, forexample, measuring 790 mm in length. The bronchoscope SO can further beconfigured from two main parts, a working head 52 and an insertion tube54. The working head 52 contains an eyepiece 56; an ocular lens with adiopter adjusting ring 58; attachments for the suction tubing 60 and asuction valve 61 and for the cold halogen light source 62 and 63; and anaccess port or biopsy inlet 64, through which various devices and fluidscan be passed into the working channel 66 and out the distal end of thebronchoscope. The working head is attached to the insertion tube, whichtypically measures 580 mm in length and 6.3 mm in diameter. Theinsertion tube can be configured to contain fiberoptic bundles (whichterminate in the objective lens 30 at the distal tip 68), two lightguides 70, 70′ and the working channel 66. The distal end of thebronchoscope has the ability to bend 72 anterior and posterior only,with the exact angle of deflection depending on the instrument used. Acommon range of bending is from 160 degrees forward to 90 degreesbackward, for a total of 250 degrees. Bending is controlled by theoperator by adjusting an angle lock lever 74 and angulation lever 76 onthe working head. See also, U.S. Patent Pub. US 2005/0288550 A1 toMathis for Lung Access Device and US 2005/0288549 A1 to Mathis forGuided Access to Lung Tissue.

FIG. 3 illustrates the use of a lung volume reduction delivery device 80for delivering a lung volume reduction device comprising an implantabledevice with the bronchoscope 50. The lung volume reduction system, asdescribed in further detail below, is adapted and configured to bedelivered to a lung airway of a patient in a delivered configuration andthen changed to a deployed configuration. By deploying the device,tension can be applied to the surrounding tissue which can facilitaterestoration of the elastic recoil of the lung. The device is designed tobe used by an interventionalist or surgeon.

FIGS. 4A-F illustrate a lung volume reduction device 110 according to anaspect of the invention, with FIGS. 4B-F being cross-sections takenalong the lines B-B, C-C, D-D, E-E and F-F of FIG. 4A, respectively. Thelung volume reduction device 110 includes a member, such as tubularmember 112, which has c-cuts 114, or notches, along its length toprovide flexibility such that the device can be deflected off alongitudinal axis A when deployed. For example, where the cuts areoriented parallel each other along the length of the tubular member andare of the same or similar depth D, the device will tend to uniformlycurve around an axis point when deployed (depicted below). As a result,the device preferentially curls or bends in a direction as determined bythe shape of the slots. Different types (width, depth, orientation,etc.) of notches or slots can be used to achieve different operationaleffects and configurations of the deployed device without departing fromthe scope of the invention.

Positioned within a lumen 113 of the tubular member 112 is an actuationelement 116 or pull-wire. The actuation element can have a circularcircumference in cross-section, as depicted, or can have any othersuitable cross-section. The actuation element 116 is anchored at one endof the device 110, e.g. the distal end, by a cap 119. The cap 119 can bebonded to the catheter and a distal crimp can be provided to crimp thecap into the pull wire. The rounded cap can also be provided to make thetip of the device atraumatic. The opposing end, e.g. proximal end, isadapted and configured to engage a mechanism 120. The mechanism enablesthe device to be deployed. The mechanism can further be adapted andconfigured to enable the device to lock into a deployed configurationonce the device 110 is deployed or unlocked to retrieve the device. Thedevice 110 is configured to be detachable from a delivery catheteradapted to deliver the lung volume reduction device (discussed below).

Mechanism 120, at the proximal end of the device, can be adapted toinclude a retainer ring 122 that engages a ratchet 124 that can be usedto lock the device in place. The coupler 126 retains the ratchet 124such that the ratchet locks the device in place once deployed. At theproximal end a retrieval adapter 130 is provided, such as a pull-wireeyelid. The retrieval adapter 130 is adapted and configured to enablethe device to be retrieved at a later point during the procedure orduring a subsequent procedure. The ratchet device has flanges thatextend away from a central axis when deployed to lock the device inplace.

Turning to FIGS. 5A-B, a lung volume reduction device 210 according toanother aspect of the invention is depicted, with FIG. 5B being across-section taken along the lines B-B of FIG. 5A. Positioned within alumen 213 of the tubular member 212 is an actuation element 216 orpull-wire. As described above, the actuation element can have a circularcircumference in cross-section, as depicted, or can have any othersuitable cross-section. The actuation element 216 is anchored at one endof the device 210, e.g. the distal end, by a cap 219. In thisembodiment, the retainer ring 222 is configured to provide anchors 223,223′ or teeth that are adapted to deploy by retracting the retainingsheath of a delivery catheter. When deployed, the anchors 223 contactthe airway and affix the device in place. The anchor 223 can beconfigured to be self-expanding such that the anchors extend away from acentral axis A of the device 210 when deployed until the anchorsapproach or extend through (e.g., hook) the airway. The amount ofexpansion of the anchors will be controlled by the design and thematerials used. For example, where a shape memory material is used, theanchors can be configured to extend away from the longitudinal wall ofthe tubular member by a predetermined angle α, as depicted ˜10 degrees.The design of the anchor can further be driven by the length of thedevice. The anchors can be configured to catch on the airway whendeployed in a manner similar to the way a stent catches within thevasculature, or the anchor can be designed to cause friction. Prior todeployment, the anchors are retrained by a retaining sheath (illustratedbelow.).

FIGS. 6A-C illustrate yet another lung volume reduction device accordingto another aspect of the invention, with FIGS. 6B-C being cross-sectionstaken along the lines B-B, and C-C of FIG. 6A, respectively. As depictedin this embodiment, the lung volume reduction device 310 includes amember, such as tubular member 312, which has c-cuts 314, 314′, ornotches, along its length to provide flexibility such that the devicecan be deflected in more than one direction off a longitudinal axis Awhen deployed. In this embodiment, the notches are positioned on themember 312 on opposing sides of the member when the member is lyingwithin a plane. For example, where the cuts are oriented parallel eachother along the length of the tubular member and are of the same orsimilar depth D, the device will tend to uniformly curve around an axispoint when deployed. In this embodiment, when deployed, theconfiguration of the notches would result in a deployed configurationthat is “s”-shaped when the actuator element 316 is pulled proximally(i.e., toward the user).

FIG. 7 illustrates yet another lung volume reduction device 410according to another aspect of the invention. In this embodiment, thetubular member 412 has notches 414, 414′, 414″ configured in a spiralpattern along its length. As a result, when the actuation element 416 ispulled proximally toward the user, the device bends to form a spiral asillustrated below.

FIG. 8 illustrates a lung volume reduction device 510 encased in asheath 535. The sheath can be a polymeric elastic membrane, such assilicone. The sheath can prevent material from a body cavity fromentering the lumen 513 of the tubular member 512. An actuation member516 is provided within the lumen 513 of the tubular member 512.

FIGS. 9A-D illustrate yet another lung volume reduction device 610according to another aspect of the invention, with FIGS. 9B-D beingcross-sections taken along the lines B-B, C-C, and D-D of FIG. 9A,respectively. The lung volume reduction device 610 in this embodiment iscomprised of individual segments 612, 612′, 612″. The segments can beconfigured, for example, to have identical asymmetrical configurationssuch that a compressible space 614 is between each segment before thedevice is actuated by activating the actuator element 616. Each of thesegments can further comprise a detent on a first surface which opposesa mating indentation on a surface of an opposing segment. As will beappreciated, a variety of components of devices disclosed herein can beconfigured to provide locking or mating mechanisms to facilitateactuation and operation. When the actuation element 616 is activated,the compressible space is reduced and the opposing surfaces of twoadjacent segments come together to reduce or eliminate the space betweenthem, depending upon the desired outcome. Where the segments haveidentical or nearly identical configurations, the device will evenly arcaround an axis point. Where the segments do not have identicalconfigurations, a variety of configurations can be achieved upondeployment depending on the configurations of the segments selected andthe organization of the segments in the device. As with previousembodiments, the actuator element 616 is secured at one end, e.g., thedistal end, by a cap 619. The segments can be formed as hypotubes or canbe formed as injection molded or solid pieces. Use of segments can avoidfatigue on the device because the surfaces come in contact with oneanother during compression. Material selection can also preventbiometallic corrosion. Further, the segment design is conducive for massproduction and maintenance of consistence for final shape and operation.

FIGS. 10A-B illustrate segments 712, 712′ suitable for use inconfiguring a lung volume reduction device according to an aspect of theinvention. The segments, as depicted, can be generally cylindrical witha pair of surfaces that are either parallel or non-parallel each otherat either end. To achieve the operation described above, a first surface713 could be perpendicular to the elongated tubular sides 715 of theelement, while the opposing surface 717 is not perpendicular to thesides of the element (or parallel to the opposing first surface). Adetent 721 can be provided on one surface that is configured to matewith an indentation 723 the second surface of another. Otherconfigurations, such as a key: keyway combination, can be used withoutdeparting from the scope of the invention. A central lumen 725 isprovided through which an actuator element (described above) passesthrough.

In another embodiment of the invention, as illustrated in FIGS. 11A-F,the device 810 is comprised of a plurality of individual wires formed ofshape memory material that resume their shape when implanted. The wirescan be heat treated to assume a specific shape, such as a C shape asdescribed above. The wires are then individually implanted through adelivery system 850 such that when the first wire is implanted thediameter of the wire may be small enough that the wire cannot overcomethe force applied by the surrounding tissue to assume its preconfiguredshape. However, upon implantation of additional wires, the amount ofstrength available cumulatively among the wires does overcome the forceapplied by the tissue and the wires, together, achieve the desired shape(see. FIG. 11F). As will be apparent to those of skill in the art, thestrength of a shaped wire can vary depending on how much material isused. For example, a shaped wire with a larger cross-section will havehigher strength than a shaped wire with a smaller cross-section.However, a larger diameter wire may be harder to implant because itwould be harder to straighten into a shape suitable for deployment.Where many small wires are used, each wire individually is more flexibleand can be deployed easier, but as a larger number of wires areimplanted the combined strength increases. In some embodiments, it maybe useful to configure the devices 810 such that the use of, forexample, 50-100 wires will have the strength to overcome pressureapplied by the tissue. The wires 810 can be deployed within a flexiblepolymer tube to keep the wires in proximity to each other.

FIG. 12 illustrates a lock feature positioned at the proximal end of alung volume reduction device such as those discussed above. The lockfeature enables the deployed device to retain tension on the actuationelement (e.g. 116) when the device is deployed. The lock mechanism 930has an eyelid 932 which is adapted to engage a pull string 933. The lockfeature normally rests on the inside of the implant and pops open toengage the tabs 934 when the ratchet 936 moves proximally P relative tothe slotted tube. A stopper 940 can also be employed in the lung volumereduction devices. A stopper is depicted in FIG. 13. The stopper isadapted to hold the tension on the deployed device. Once the actuationelement has been engaged and the desired amount of tension is appliedwhich results in a desired shape of the device, the stopper can bedeployed to maintain the tension on the device. The stopper can beconfigured as depicted with a slotted tube forming flanges 942 adaptedto fit within a cap 944. Each of the flanges can be formed of shapememory material such that the flanges will tend to extend away from acentral axis A to engage the interior surface of the cap 944.

Turning now to FIGS. 14A-C, a self-locking mechanism 1040 suitable forthe proximal end of a lung volume reduction device of the invention isdepicted, with FIGS. 14B-C being cross-sections taken along the linesB-B, and C-C of FIG. 14A, respectively. One or more flanges 1042 areprovided. The flanges 1042 can be configured such that the flangesdeflect away from a central axis A when not constrained. Thus, as shownin FIGS. 14B-C, the flanges 1042 are positioned to engage the sides ofthe of the self locking mechanism 1040. The flanges can be configuredsuch that they form cut-outs that extend from the device, or can beintegrally formed such that the self-locking mechanism still forms asolid tube when the flanges are deployed. FIG. 14C depicts the deployedflanges withdrawn from a retaining tube 1050 of the implant. Theinterference between the end of the flange and the sides of theretaining tube can be used to prevent, for example, the tap or ratchetfrom going back into the implant.

The component depicted in FIGS. 15A-C is a ratchet design used to holdthe device in place until the delivery device, e.g. catheter, isdecoupled. The device is configured to provide a ratchet mechanismhaving a ratchet wheel and pawl within the interior surface of theproximal end of the device. A retaining sheath 1152 is provided to holdthe ratchet mechanism and prevent it from opening up. The sheath isretracted and then the pull wire 1116 is pulled out. Flanges or tabs1142 are provided that extend away from a central axis when notconstrained. A pin 1154 can be provided that slides within a slot 1156in the tube 1155 and is engaged at a widened aperture 1156′. Whenwithdrawing the pull wire 1116 the sides of the ratchet can deform awayfrom the central axis A as shown in FIG. 15C to allow the pull wire toexit. The ratchet tube 1158 can be formed of shape memory material, suchas nitinol which can heat set the ratchet to open once the sheath 1152is removed. Alternatively, the ratchet tube can be formed from stainlesssteel. Use of stainless steel would require the pull wire with the pegto be pulled out. FIG. 15D is a cross-section taken along the lines D-Dof FIG. 15A.

FIGS. 16A-C illustrate yet another mechanism suitable for use with theimplantable devices of the invention, wherein a detent 1254 positionedon the inner surface of the ratchet tube 1258. Two tubes 1257, 1257′ areused to lock the device in place. Once the first tube 1257 is pulledout, the second tube 1257′ can deflect away from the detent 1254,thereby unlocking the coupling. The detent 1254 can be configured in theshape of a ball as depicted in the cross-section shown in FIG. 16C. Thissystem can be used to de-couple the delivery device.

FIGS. 17A-B and 18 depict alternative mechanisms for de-coupling thedelivery device. As depicted in FIGS. 17A-B, a push bar 1357′ is used topush back a latch bar 1357. The latch bar is adapted to engage a lip onthe interior of the device, the push bar deflects the latch bar awayfrom the lip 1359 and enables the bar to be withdrawn as shown in FIG.17B. In FIG. 18, a retaining sheath 1460 is employed which, whenwithdrawn in the proximal direction, enables the arms of the latchdevice 1458 to deflect away from a central axis A and disengage from aretaining lip 1459. FIGS. 19A-B illustrates yet another embodiment. Inthe embodiment illustrated, a central pin 1557 is withdrawn which allowsthe claws 1555 to relax and withdraw away (toward a central axis) fromretaining lip 1559 of latch bar 1558.

FIGS. 20A-E illustrates a hitch pin configuration useful for use inactuating and de-coupling the delivery device. A portion of the lungvolume reduction device 1610 is depicted with an actuation element 1616positioned therein. A locking mechanism 1640 such as depicted in FIG. 14engages the proximal end of the device 1610. A hitch pin de-couplingsystem 1662 is attached to the locking mechanism 1640. Alternatively,the hitch pin can be adapted to decouple from the ratchet mechanism. Thehitch pin system 1662 has a hitch pin wire 1664 that engages a hitch pin1666 loop wire. When the hitch pin wire is inserted it maintains thehitch pin in contact with the locking shaft 1668.

FIG. 21 illustrates an activation mechanism suitable for use with theinvention. The activation mechanism 1770 has a handle 1771 which a usercan squeeze to activate the device. Two levers 1772, 1772′ of the handlewill be advanced toward each other as the user squeezes the leverstogether. Stoppers 1773 can be provided to control or pre-set the amountof pulling the activation mechanism can achieve in a single squeeze. Theamount of displacement of wire at the distal end is indicated by thedisplacement x from a vertical axis that occurs of hinged lever 1774positioned between the two levers of the activation mechanism when theuser squeezes the levers together. FIG. 22 illustrates an alternativemechanism for proximally controlling the deployment of the device. Asillustrated in FIG. 22 a pistol actuator 1870 is provided that has atrigger 1872 which can be pulled back toward a handle 1871. The amountof displacement of the wire can be controlled by the distance x that thetrigger is pulled toward the handle. A linear actuation motion can alsobe simulated by using spur gears 1890 having teeth machined parallel toits axis, such as that shown in FIG. 23.

FIG. 24 illustrates another proximal control mechanism 1970 adapted foruser control of the delivery device and implant. The control mechanismincludes a hand grasper 1972, 1972′ with four-bar linkages 1974. When auser presses down on the hand grasper, the device adapts itsconfiguration from angled to flat, which pulls the catheter proximally(toward the user) to actuate the implant within the patient.

The device illustrated in FIG. 25 is another proximal control mechanism2070 adapted for the user to control the temperature of a Nitinolself-recovering implant during the deployment process. In thisembodiment, cold saline is advanced distally 2071 to maintain theNitinol implant in a martensitic state (i.e., a state having a “soft”microstructure that allows deformation). A return path 2071′ is providedto bring the saline back to the mechanism for cooling. Maintenance ofthe martensitic state enables the device to remain flexible and softduring implant delivery without modifying the implant's programmedshape. Chilled saline, liquid nitrogen, liquid CO₂ or other suitablematerials that are colder than body temperature, can be pumped 2072 orcirculated to the implant. A chiller 2073 can be provided to cool downthe material circulating to the device on its return path. In someembodiments, it may be desirable to control the temperature of thedevice, e.g., during the implantation process with a distal temperaturesensor and feedback that may be transmitted via electric signal on awire or electro-magnetic waves in a wireless fashion.

Turning now to FIG. 26, a distal configuration of a recapture device2080 is depicted. The proximal end of the implanted device 2010 isengaged by the recapture device 2080 which is adapted to encircle theexterior of the implanted device. The device comprises a high pressureballoon 2081 adapted to engage a recovery catheter. An inflation port2082 is provided through which, for example, cold fluid can be pumped tofacilitate deflecting the nitinol tabs 2034. Once the tabs are deflectedand moved toward the central axis A of the device, the lock mechanismholding the actuation wire in a curved condition can be released, theimplanted device straightened and withdrawn. FIGS. 27A-B illustrates analternative embodiment of a retrieval device 2180, where forceps areused to provide lateral force on the tabs, thus pressing the tabs intoward the central axis of the device to enable the lock mechanismholding the actuation wire to be released as described above. Asillustrated in FIG. 27B, the forceps can then withdraw the straighteneddevice by pulling on the device.

A variety of mechanisms can be used to couple the clip of the device tothe catheter. As shown in FIGS. 28A-B, the implantable device 2210 has aring with a key 2291 associated with one of the device or the deliverycatheter and a keyway 2292 associated with an opposing ring associatedwith remaining one of the device or delivery catheter. As will beappreciated by those skilled in the art, more than one key or keyway canbe provided, as desired, to control the torque. As shown in FIG. 28B,the two rings are adapted to abut each other to lock the device andallow transfer for torque between the catheter and the device. The key:keyway design illustrated in FIG. 28B can also be applied to thedelivery or retrieval of devices and to the proximal end of the device.

FIGS. 29A-C illustrates another retrieval mechanism 2380. The retrievalmechanism employs a hook 2393 adapted to hook into a loop 2394 at theproximal end of the device. The hook can be incorporated into theactuation mechanism 2316 such that hook 2393 extends from the actuationmechanism at the proximal end of the device 2310. Once hooked theapparatus de-activates the locking mechanism, which releases the tensionon the actuator 2316. The catheter is then advanced to engage thelocking flanges 2334 to push them in toward a central axis A, unlockingthe device 2310 by removing tension from the actuation member 2316 andallowing the device to be withdrawn or relocated. In yet anotherembodiment illustrated in FIGS. 30A-B, a hypotube 2495 associated with,for example, a catheter is adapted to slide over the proximal end of thedevice 2410. A snare wire 2496 is configured to fit over the proximalend of the device much like a lasso. In operation, the snare wire 2496is looped over the proximal end of the device 2410, and pulledproximally to push the hypo tube distally toward the device. Thisenables the combination to hold onto the implant, advance the lockinghypo tube forward to unlock the tabs or flanges 2434.

FIGS. 31A-D illustrates devices 2510 according to the invention in avariety of deployed configurations. FIG. 31A illustrates the device 2510having a longitudinal configuration, such as the configuration assumedprior to deployment. When the device is implanted and placed incompression or tension axially, the device will preferentially bend. Theactual preferential bending will vary depending upon the configurationof the device. For example, the location, depth, and orientation of theslots depicted in FIGS. 4-8; or the orientation of the walls of thesegments of FIG. 9. As FIG. 31B illustrates, for example, where thedevice 2510 has evenly spaced c-cuts or notches along its length thedevice will preferentially bend such that the walls of forming the “c”or notch will approach each other, or pinch together, resulting in adeployed device that has preferentially bent into a curved “c” shape(see, FIGS. 4-5). This results because as tension is applied on theactuation device, or wire, the implant deforms and the wire takes ashorter path. FIG. 31C illustrates a device deployed into an “S” shape,such as would be achieved using a configuration like that depicted inFIG. 6. As will be appreciated, the S-shape could continue, much like asine wave, in an many curves as desired depending upon the configurationof the device. FIG. 31D illustrates a device deployed into a spiralconfiguration (see FIG. 7). As will be appreciated by those skilled inthe art upon reviewing this disclosure, other configurations can beachieved by, for example, altering the size and location of the c-cutson the tubular member, or by altering the configuration of the segmentsillustrated in FIGS. 9-10. Once the device preferentially bends, thedevice imparts a bending force on the lung tissue which results in areduction of lung volume. As is appreciated, from the configurationsshown in FIG. 31 the implant, once re-shaped, is shorter in length thanthe deliverable implant configuration. The shortening occurs when forexample, the distance between the proximal end and the distal end isreduced. Typically, the deliverable shape of the device is such that itfits within a cylindrical space that is 18 mm in diameter or smaller.Thus, the implant can come into contact with tissue that is larger than10⁻⁶ square inches per linear inch of the implant length. The re-shapedor deployed implant can be configured in a variety of shapes to liewithin a single plane, or to adopt any other suitable configuration,such that it does not lie within a single plane. Additionally, thedevice can have varying rates of curvature along its length.

FIG. 32 illustrates a lung volume reduction device 2610 in combinationwith a delivery device 2680. The device 2610 is adapted to provide atubular member 2612 having a lumen 2613 through which an actuationelement 2614 is provided. The tubular member 2612 has a series of c-cuts2614 along its length that enable the device to preferentially bend whendeployed. As will be appreciated, for purposes of illustration, a devicesimilar to that depicted in FIG. 4 has been illustrated. Other devicescan be used without departing from the scope of the invention. A device2680 is provided that engages flanges 2634 of a lock mechanism to pushthe flanges in toward a central axis enabling tension applied to theactuation element 2614 to be relieved, thus enabling the device to beremoved. The device can be activated by pulling the central rod in aproximal direction. The decoupler (outer rod) is then pulled in theproximal direction.

FIGS. 33A-C illustrates devices 2710 according to the inventionimplanted within, for example, a bronchiole 26. The device 2710 depictedin FIG. 33A is configured to provide an atraumatic tip 2711 on eitherend of the device. When the device 2710 is activated within thebronchiole 26 the device curves and imparts a bending force on the lungtissue. As a result of the bending pressure, the tissue curves andcompresses upon its self to reduce lung volume. Additionally, deploymentof the device can result in the airway becoming bent. As illustrated inFIG. 33C the device can also be configured with a single atraumatic tipso that the deployment mechanism 2720 can easily interface with theproximal end of the device.

In some instances, where the device has been implanted for a length oftime sufficient for tissue in-growth to occur, a torquable catheter 2750having a sharp blade (not shown) within its lumen can be advanced alongthe length of the device 2710 to enable tissue to be cut away from theimplant prior to withdrawal such as shown in FIGS. 34A-B. This enablesthe device to be cut away from the airway wall in order to facilitatewithdrawal.

FIG. 35A-C illustrates the process of implanting the device within alung. As is evidence, the device 2810 is advanced is a configurationwhere the device adapts to the anatomy of the lungs through the airwaysand into, for example, the bronchioles until it reaches a desiredlocation relative to the damaged tissue 32. The device is then activatedby engaging the actuation device, causing the device to curve and pullthe lung tissue toward the activated device (see FIG. 35B). The devicecontinues to be activated until the lung tissue is withdrawn a desiredamount, such as depicted in FIG. 35C. As will be appreciated by thoseskilled in the art, withdrawing the tissue can be achieved by, forexample, curving and compressing a target section of lung tissue upondeployment of one of the configurable devices disclosed herein. Onceactivated sufficiently, the deployment device is withdrawn from the lungcavity.

A variety of steps for performing a method according to the inventionwould be appreciated by those skilled in the art upon review of thisdisclosure. However, for purposes of illustration, FIG. 36A illustratesthe steps including, insertion of the device 3610, activating the device3620, such as by activating an actuator; bending the device into adesired configuration 3630 and locking the device into a deployedcondition. As will be appreciated the step of bending the device can beachieved by activating the actuator, as described above, or by theimplant being restored into a preconfigured shape.

In one embodiment, the device operation includes the step of inserting abronchoscope into a patient's lungs and then inserting anintra-bronchial device or lung volume reduction device into thebronchoscope. The intra-bronchial device is then allowed to exit thedistal end of the bronchoscope where it is pushed into the airway. Avariety of methods can then be used to verify the positioning of thedevice to determine if the device is in the desired location. Suitablemethods of verification include, for example, visualization viavisualization equipment, such as fluoroscopy, CT scanning, etc.Thereafter the device is activated by pulling the pull wire proximally(i.e., toward the user and toward the exterior of the patient's body).At this point, another visual check can be made to determine whether thedevice has been positioned and deployed desirably. Thereafter, thedevice can be fully actuated and the ratchet can be allowed to lock andhold the device in place. Thereafter, the implant is decoupled from thedelivery catheter and the delivery catheter is removed.

Another method of tensioning the lung is shown in FIG. 36B whichillustrates steps that include, applying bending loads or force tostrain a device from a first shape into a deliverable shape withoutplastically or permanently bending the device 3640, delivering thedevice into the patient using the bronchoscope or other delivery systemcomponents to hold the device in a deliverable shape while it is beingintroduced 3650 and then removing the constraint used to hold the deviceto allow it to recover back to its first shape 3660. Elastic recovery ofthe device will drive the device to a more bent condition that willapply force to nearby lung tissue. The bending forces locally compresstissue near the implant and apply tension on lung tissue in surroundingregions to restore lung recoil and enhance breathing efficiency. Thefirst shape is adapted to be elastically constrained by a deliverydevice to a deliverable configuration whereby removal of the deliverydevice allows the implant to recoil and be reshaped closer to its firstshape.

FIG. 37 shows an example of an implantable device 3703 made from Nitinolmetal wire 3701. Nickel-Titanium, Titanium, stainless steel or otherbiocompatible metals with memory shape properties or materials withcapabilities to recover after being strained 1% or more may be used tomake such an implant. Additionally, plastics, carbon based composites ora combination of these materials would be suitable. The device is shapedlike a French horn and can generally lie in a single plane. The ends areformed into a shape that maximizes surface area shown in the form ofballs 3702 to minimize scraping or gouging lung tissue. The balls may bemade by melting back a portion of the wire, however, they may beadditional components that are welded, pressed or glued onto the ends ofwire 3701.

A Nitinol metallic implant, such as the one illustrated in FIG. 37, maybe configured to be elastic to recover to a desired shape in the body asany other type of spring would or it can be made in a configuration thatmay be thermally actuated to recover to a desired shape. Nitinol can becooled to a martensite phase or warmed to an austenite phase. In theaustenite phase, the metal recovers to its programmed shape. Thetemperature at which the metal has fully converted to an austenite phaseis known as the Af temperature (austenite final). If the metal is tunedso that the Af temperature is at body temperature or lower than bodytemperature, the material is considered to be elastic in the body and itwill perform as a simple spring. The device can be cooled to induce amartensite phase in the metal that will make the device flexible andvery easy to deliver. As the device is allowed to heat, typically due tobody heat, the device will naturally recover its shape because the metalis making a transition back to an austenite phase. If the device isstrained to fit through a delivery system, it may be strained enough toinduce a martensite phase also. This transformation can take place withas little as 0.1% strain. A device that is strain induced into amartensite phase will still recover to its original shape, and convertback to austenite after the constraints are removed. If the device isconfigured with an Af temperature that is above body temperature, thedevice may be heated to convert it to austenite and thermally activateits shape recovery inside the body. All of these configurations willwork well to actuate the device in the patient's lung tissue. The humanbody temperature is considered to be 37 degrees C. in the typical humanbody.

FIG. 38 illustrates a cutaway view of a delivery cartridge system 3800that constrains the implant device 3703 in a deliverable shape. Thedevice 3801 may be shipped to the intended user in such a system or itmay be used as a tool to more easily load the implant into a desiredshape before being installed into the patient, bronchoscope or acatheter delivery device. The cartridge may be sealed or terminated withopen, ends or one or more hubs such as the Luer lock hub 3802 that isshown. The implant should be constrained to a diameter that is the sameor less than 18 mm diameter because anything larger than that will bedifficult to advance past the vocal cord opening.

FIG. 39 illustrates another implant device 3901 that is shaped in athree dimensional shape similar to the seam of a baseball. The wire isshaped so that proximal end 3902 extends somewhat straight and slightlylonger than the other end. This proximal end will be the end closest tothe user and the straight section will make recapture easier. If it werebent, it may be driven into the tissue making it hard to access.

FIG. 40 is an illustration of another implant system 4001, it is similarto that shown in FIG. 39 with the addition of a wire frame 4002surrounding the device. The wire frame may be used, for example, toincrease the bearing area that is applied to the lung tissue. Byincreasing the bearing area, the pressure born by the tissue is reducedalong with a reduction in the propensity for the device to grow throughlung structures or cause inflammatory issues. Small wires that applyloads in the body tend to migrate so we believe that the device shouldbe configured to possess more than 0.000001 (1⁻⁶ in²) square inches ofsurface area per linear inch of the length of the device. The frame isone of many ways to provide a larger surface area to bear on the tissue.

FIG. 41 shows yet another example of a device 4101 according to theinvention. The device 4101 features a covering to increase bearing area4102. In this example, the main wire 3902 is covered by a wire frame anda polymeric covering 4102. The covering may be made of any biocompatibleplastic, thermoplastic, fluoropolymer, Teflon®, urethane, metal mesh,coating, silicone or other resilient material that will reduce thebearing pressure on the lung tissue. The ends of the covering 4103 mayremain sealed or open as shown to allow the user to flush antibioticsinto and out of the covering.

FIG. 42 illustrates another configuration of the implant device 4201showing a covering 4205 with perforations 4203 adapted and configured toallow the device to be flushed. The ends 4202 of the covering are sealedto the ends of the device to keep the two components fixed and preventsliding of one or the other during deployment. The covering may bethermally bonded, glued or shrunk to a tight fit.

FIG. 43 illustrates a device 4301 that has the wire frame 4002 joined tothe ball ends 3702 at a junction 4302. The balls may be melted from thewire stock and the wire frame may be incorporated into the ball at thattime. It may also be glued, pressed together, welded or mechanicallylocked together.

FIG. 44 illustrates another implant device 4401 with an attached wireframe 4302, main wire 4103 and a covering 4102.

FIG. 45 illustrates a system of one or more devices that can be hookedtogether 4501. The device 3703 is configured such that it terminates onboth ends, for example, with blunt ball shaped ends 3702. The device4502 is terminated on one end with an open cup and slot shape 4503 thatallows the devices to be coupled together. These devices may bedelivered together or coupled in-situ. Devices may be installed into asingle duct in the lung or in different locations that may be linkedtogether.

FIG. 46 illustrates another three dimensional device 4601 made in theform of a coil with ball terminations 3702.

FIGS. 47 and 48 illustrate how the device length is reduced when thedevice is deployed in-situ. The device shown in the deliveryconfiguration 4802 in FIG. 47 is also shown in the deployedconfiguration 4803 in FIG. 48. The distance A between the device ends3702 is large while the device is constrained by the constrainingcartridge device 3801. Distance A is similar when the device isconstrained by a loading cartridge, catheter or bronchoscope. FIG. 48shows the same device in a deployed configuration 4803 in an airway 4801that has been deformed by the shape recovery of the implant device. FIG.48 shows that the distance B between the device ends 3702 issubstantially shorter after the device is deployed.

As with previous embodiments, the embodiments depicted in FIGS. 37-48are adapted and configured to be delivered to a lung airway of a patientin a delivery configuration and to change to a deployed configuration tobend the lung airway. The devices are characterized in that the deviceshave a delivery configuration that is resiliently bendable into aplurality of shapes, such as the ones depicted in the Figures. Thedesign of the devices can be such that strain relief is facilitated onboth ends of the device. Further the ends of the device in either thedelivery or deployed state are more resilient.

The devices can have any suitable length for treating target tissue.However, the length typically range from, for example, 2 cm to 10 cm,usually 5 cm. The diameter of the device can range from 1.00 mm to 3.0mm, preferably 2.4 mm. The device is used with a catheter which has aworking length of 60 cm to 200 cm, preferably 90 cm.

In operation the devices shown in FIGS. 37-48 are adapted and configuredto be minimally invasive which facilitates easy use with a bronchoscopeprocedure. Typically, there is no incision, and no violation of thepleural space of the lung during deployment. Furthermore, collateralventilation in the lung does not affect the effectiveness of theimplanted device. As a result, the devices are suitable for use witheither homogeneous and heterogeneous emphysema.

Each of the devices depicted in FIGS. 37-48 are adapted and configuredto impart bending force on lung tissue. For example, a spring elementcan be provided, as illustrated in FIG. 40 that imparts bending force onlung tissue. The implantable spring element that can be constrained intoa shape that can be delivered to a lung airway and unconstrained toallow the element to impart bending force on the airway to cause theairway to be bent.

Embodiments of the lung volume reduction system can be adapted toprovide an implant that is constrained in a first configuration to arelatively straighter delivery configuration and allowed to recover insitu to a second configuration that is less straight configuration.Devices and implants can be made, at least partially, of spring materialthat will fully recover after having been strained at least 1%, suitablematerial includes a metal, such as metals comprising Nickel andTitanium. In some embodiments, the implant of the lung volume reductionsystem is cooled below body temperature in the delivered configuration.In such an embodiment, the cooling system can be controlled by atemperature sensing feedback loop and a feedback signal can be providedby a temperature transducer in the system. The device can be configuredto have an Af temperature adjusted to 37° Celsius or colder.Additionally, at least a portion of the metal of the device can betransformed to the martensite phase in the delivery configuration and/orcan be in an austenite phase condition in the deployed configuration.

Lung volume reduction systems, such as those depicted in FIGS. 37-48,comprise an implantable device that is configured to be deliverable intoa patient's lung and which is also configured to be reshaped to make thelung tissue that is in contact with the device more curved. Increasingthe curvature of the tissue assists in reducing the lung volume ofdiseased tissue, which in turn increases the lung volume of healthiertissue. In some instances, the devices are configured to be reshaped toa permanent second configuration. However, as will be appreciated bythose skilled in the art, the devices can also be adapted and configuredto have a first shape and is configured to be strained elastically to adeliverable shape.

As will be appreciated by those skilled in the art, the devicesillustrated in FIGS. 37-48 are can be configured to be deliverable intoa patient's lung and configured to reshape lung tissue while allowingfluid to flow both directions past the implant.

FIG. 49 illustrates a system 4901 that may be used to deliver theimplant device. The many components of the system may be needed to guidethe bronchoscope 4902 to a site that is appropriate for implantdelivery. The airway guide wire has a distal floppy section 4913 thatcan be steered into any desired airway by rotating the slight curve atthe distal tip to the appropriate trajectory at airway bifurcations. Toapply torque to the wire, devices such as a locking wire steering handle4915 may be attached to the proximal end of the wire 4912. The wire tipmay be blunt such as the ball tip shown 4914. In some embodiments, thewire may be adapted and configured to pass through a dilator catheter4909 that is shaped to provide a smooth diameter transition from thewire diameter to the delivery catheter 4906 diameter. The distal tip ofthe dilator 4910 should be tapered 4911 as shown. The dilator preventsthe open end of the delivery catheter 4906 to dig into lung tissue in anunintended way. The dilator hub 4916 may be made as a Y-fitting to allowthe user to couple a syringe and inject radiopaque dye through thedilator lumen to increase the visibility of the airways, whichfacilitates the use of an x-ray guidance system, such as fluoroscopy orcomputed tomography. The delivery catheter may be used without the wireand dilator. The catheter 4906 is designed to constrain the device in adeliverable shape while it is advanced through the system and into thepatient. The distal end 4907 may be configured from a floppier polymeror braid than the proximal end 4906 and the distal tip may furtherinclude a radiopaque material associated with the tip, either integralor adjacent, to identify the position of the tip relative to otheranatomical locations, such as bones. Providing one or more radiopaquemarkers facilitates using x-ray guidance system to position the distalend of the device in situ relative to a target anatomy. The proximaltermination of the delivery catheter 4908 may further be adapted toincorporate a lockable hub to secure the loading cartridge 3801 with asmooth continuous lumen. The delivery catheter 4906 is shown introducedinto the bronchoscope side port 4905 and out the distal end of the scope4917. A camera 4903 is shown attached to the end of the scope with acable 4904, or other delivery mechanism, to transmit the image signal toa processor and monitor. The loading cartridge, delivery catheter,dilator, guide wire and wire steering handle may be made from anymaterial identified in this specification or materials well known to beused for similar products used in the human vascular tract byradiologists.

FIG. 50 illustrates a delivery system 5001 that has been placed into ahuman lung. The bronchoscope 4902 is in an airway 5002. The scope camera4903 is coupled to a video processor 5004 via a cable 4904. The image isprocessed and sent through a cable 5005 to a monitor 5006. The monitorshows a typical visual orientation on the screen 5007 of a deliverycatheter image 5008 just ahead of the optical element in the scope. Thedistal end of the delivery catheter 4907 protrudes out of the scope inan airway 5002 where the user will place an implant device 3703. Theimplant 3703 is loaded into a loading cartridge 3801 that is coupled tothe proximal end of the delivery catheter via locking hub connection3802. A pusher grasper device 5009 is coupled to the proximal end of theimplant 3703 with a grasper coupler 5010 that is locked to the implantusing an actuation plunger 5012, handle 5011 and pull wire that runsthrough the central lumen in the pusher catheter. By releasably couplingthe pusher to the implant device, the user may advance the implant to aposition in the lung in a deployed configuration. The user can surveythe implant placement position and still be able to retrieve the implantback into the delivery catheter, with ease, if the delivery position isless than ideal. The device has not been delivered and the bottomsurface of the lung 5003 is shown as generally flat and the airway isshown as generally straight. These are both anatomically correct for alung with no implant devices. If the delivery position is correct, theuser may actuate the plunger 5012 to release the implant into thepatient.

FIG. 51 illustrates generally the same system after the implant has beendeployed into the airway 5103. The implant 5102 and pusher 5101 has beenadvanced through the delivery catheter 4907 to a location distal to thescope 4902. The pusher grasping jaws 5010 are still locked onto theproximal end of the implant 5102 but the implant has recovered to apre-programmed shape that has also bent the airway 5103 into a foldedconfiguration. By folding the airway, the airway structure has beeneffectively shortened within the lung. Since the airways are wellanchored into the lung tissue, the airway provides tension on thesurrounding lung tissue which is graphically depicted by showing thepulled (curved inward) floor of the lung 5104. The image from the camera4903 is transmitted through the signal processor 5004 to the monitor5006 to show the distal tip of the delivery catheter 5101, distalgrasper of the pusher 5010 and proximal end of the implant 3703. Thegrasper may be used to locate, couple to and retrieve devices that havebeen released in the patient. It is easy to envision how the implantperforms work on the airways and lung tissue without blocking the entirelumen of the airway. This is a benefit in that fluid or air may passeither way through the airway past the implant device.

FIGS. 52A and 52B show an implant 5300 for treating airway 5002 of alung. As indicated above, airway 5002 comprises a portion of a branchingairway system, and the airway targeted for deployment will typicallydefine an airway axis 5340. Implant 5300 comprises an elongate body 5301having a distal end 5303, and a proximal end 5305. Elongate body 5301 isbiased to bend to a bent deployed configuration as described above andas shown in FIG. 52B. A pusher grasper device 5009 is coupled to theproximal end 5305 with a grasper coupler 5010 that is releasably lockedto implant 5300 using an actuation plunger 5012, handle 5011, and pullwire that runs through the central lumen in the pusher catheter. Priorto deployment, implant 5300 may be loaded into a tubular loadingcartridge, for example, cartridge 3801, and advanced from the loadingcartridge into the lumen of catheter 5301. Pusher grasper device 5009can advance implant 5300 through delivery catheter 5201. As shown inFIG. 52A, when restrained within delivery catheter 5201, elongate body5301 is maintained in a straightened configuration by the surroundingcatheter body, so that the elongate body defines a generally straightaxis 5307 between the distal end 5303 and proximal end 5305. As shown inFIG. 52B, when pusher grasper device 5009 axially restrains implant 5300and catheter 5201 is pulled proximally from airway axial region 5002,implant 5300 resiliently returns to a bent deployed configuration tobend the airway 5002. More specifically, the airway axis 5340 goes froma relatively straight configuration to a highly bent configurationhaving an axis with significant bends, with lateral movement of theelongate body and surrounding airway structure thereby compressingadjacent tissue. Once catheter 5201 has been withdrawn from overelongate body 5301, the deployment can be evaluated. The user mayaxially restrain the implant 5300 while catheter 5201 is advancedaxially so as to recapture the implant if the deployment does not appearsatisfactory, or actuate plunger 5012 to release implant 5300.

FIG. 53A shows an implant 5400 for treating an airway of the lung.Implant 5400 comprises an elongate body having a first or proximalimplant portion 5400A and a second or distal implant portion 5400B.Implant 5400 further comprises a third implant portion 5400C and afourth implant portion 5400D between proximal portion 5400A and distalportion 5400B. First portion 5400A of implant 5400 defines a first localaxis 5401A. Second portion 5400B defines a second local axis 5401B.Third portion 5400C defines a third local axis 5401C. Fourth portion5400D defines a fourth local axis 5401D. Note that the portion of theelongate body advanced along the local axis can optionally be straightbut will often be curved. Nonetheless, an elongate portion can be seento extend along the local axis, presenting an elongate bearing surfaceto engage and press against the surrounding airway. The ends of implant5400 are formed into a shape that engages a surrounding luminal surfacewith an autramatic surface area shown in the form of balls 5402 tominimize perforation through the airway luminal wall. The balls may bemade by melting back a portion of implant 5400, however, they may beadditional components that are welded, pressed or glued onto the ends ofimplant 5400.

As shown in FIGS. 53A-B, first portion 5400A, second portion 5400B,third portion 5400C, and fourth portion 5400D may traverse a plane 5420,and FIG. 53B illustrates the orientation of compressive forces appliedby the local portions of the elongate body in plane 5420. First portion5400A may intersect plane 5420 at a first point 5422A. Second portion5400B may intersect plane 5420 at a second point 5422B. Third portion5400C may intersect plane 5420 at third point 5422C. Fourth portion5400D may intersect plane 5420 at fourth point 5422D. Intermediateportions 5425 of the elongate body disposed between portions 5400A,5400B, 5400C, and 5400D may be biased so that when implant 5400 isplaced in an airway in a straight configuration, and when implant 5400bends from the straight configuration to a bent configuration, firstportion 5400A, second portion 5400B, third portion 5400C, and/or fourthportion 5400D are urged toward each other. More specifically, andlooking at just two of the portions as shown in FIGS. 53A and 53B, firstportion 5400A and second portion 5400B will often define a surfacetherebetween, such as compression plane 5423 (particularly where theportions are relatively flat). The first and second portions compresstissue disposed between them and near compression plane 5423, so that animplant that remains substantially planer can compress a volume oftissue. However, by also compressing tissue using portions of theelongate body that are significantly offset from compression plane 5423(such as third portion 5400C and forth portion 5400D), a larger volumeof lung tissue may be compressed. Compressed area 5424 may berepresentative of a cross-section of the compressed volume of lungtissue, showing how the use of additional portions of the implant thatare not co-planar can enhance compression efficacy. While the abovedescription references a compression plane for simplicity, as can beunderstood with reference to the illustrations of the three dimensionalimplants of FIGS. 31D, 39-42, 46, and the like, the implant can beconfigured with shapes that compress roughly spherical volumes, roughlycylindrical volumes, or other desired shapes.

FIG. 53C shows implant 5400 placed into an airway, with only portions ofthe implant and airway shown for simplicity. The airway comprises afirst proximal airway axial region 5410A, a second distal airway axialregion 5410B, and a third airway axial region 5410C and a fourth airwayaxial region 5410D between the first airway axial region 5410A andsecond airway axial region 5410D. First airway axial region 5410Adefines a first local airway axis 5411A. Second airway axial region5410B defines a second local airway axis 5411B. Third airway axialregion 5410C defines a third local airway axis 5411C. Fourth airwayaxial region 5410D defines a fourth local airway axis 5411D. Firstairway axial region 5410A, second airway axial region 5410B, thirdairway axial region 5410C, and fourth airway axial region 5410D eachhave inner luminal surfaces 5413. First airway axial region 5410A,second airway axial region 5410B, third airway axial region 5410C, andfourth airway axial region 5410D are coupled together axially. Firstimplant portion 5400A of implant 5400 can engage with first airway axialregion 5410A. Second implant portion 5400B of implant 5400 can engagewith second airway axial region 5410B. Third implant portion 5400C ofimplant 5400 can engage with third airway axial region 5410C. Fourthimplant portion 5400D of implant 5400 can engage with fourth airwayaxial region 5410D. Implant 5400 can urge first airway axial region5410A, second airway axial region 5410B, third airway axial region5410C, and/or fourth airway axial region 5410D laterally toward eachother by having respective implant portions urging against inner luminalsurfaces 5413, thereby imposing a bend in the airway system andcompressing the volume of lung tissue disposed between first airwayaxial region 5410A, second airway axial region 5410B, third airway axialregion 5410C, and/or fourth airway axial region 5410D. The compressedvolume of lung tissue may be sufficiently large and may be compressedsufficiently to increase tension in an uncompressed volume of the lungsuch that lung function of the lung is increased.

As will be appreciated by those skilled in the art, the device can bemanufactured and deployed such that it is deliverable through abronchoscope. When actuated, the device can be adapted and configured tobend or curl which then distorts lung tissue with which the device comesin contact. Lung tissues that may be beneficially distorted by thedevice are airways, blood vessels, faces of tissue that have beendissected for introduction of the device or a combination of any ofthese. By compressing the lung tissue, the device can result in anincrease in elastic recoil and tension in the lung in at least somecases. Additionally, in some instances, lung function can be at leastpartially restored regardless of the amount of collateral ventilation.Further, the diaphragm may, in some instances, move up once greatertension is created which enables the lung cavity to operate moreeffectively.

Devices according to the invention have a small cross-section, typicallyless than 10 F. The flexibility of the device prior to deploymentfacilitates advancement of the device through the tortuous lung anatomy.Once deployed, the device can remain rigid to hold and maintain a tissuedeforming effect. Further, the device design facilitates recapture,de-activation and removal as well as adjustment in place.

Candidate materials for the devices and components described hereinwould be known by persons skilled in the art and include, for example,suitable biocompatible materials such as metals (e.g. stainless steel,shape memory alloys, such a nickel titanium alloy (nitinol), titanium,and cobalt) and engineering plastics (e.g. polycarbonate). See, forexample U.S. Pat. No. 5,190,546 to Jervis for Medical DevicesIncorporating SIM Memory Alloy Elements, and U.S. Pat. No. 5,964,770 toFlomenblit for High Strength Medical Devices of Shape Memory Alloy. Insome embodiments, other materials may be appropriate for some or all ofthe components, such as biocompatible polymers, includingpolyetheretherketone (PEEK), polyarylamide, polyethylene, andpolysulphone.

Polymers and metals used to make the implant and delivery system shouldbe coated with materials to prevent the formation and growth of granulartissue, scar tissue and mucus. Many of the drugs used with stentproducts to arrest hyperplasia of smooth muscle cells in blood vesselsafter deploying metallic stents will work very well for these devices.Slow release drug eluting polymers or solvents may be used to regulatethe release of drugs that include any substance capable of exerting atherapeutic or prophylactic effect for a patient. For example, the drugcould be designed to inhibit the activity of smooth muscle cells. It canbe directed at inhibiting abnormal or inappropriate migration and/orproliferation of smooth muscle cells to inhibit tissue mass buildup. Thedrug may include small molecule drugs, peptides or proteins. Examples ofdrugs include antiproliferative substances such as actinomycin D, orderivatives and analogs thereof (manufactured by Sigma-Aldrich ofMilwaukee, Wis., or COSMEGEN available from Merck). Synonyms ofactinomycin D include dactinomycin, actinomycin IV, actinomycin₁,actinomycin X₁, and actinomycin C₁. The active agent can also fall underthe genus of antineoplastic, anti-inflammatory, antiplatelet,anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic,antiallergic and antioxidant substances. Examples of suchantineoplastics and/or antimitotics include paclitaxel (e.g. TAXOL® byBristol-Myers Squibb Co. of Stamford, Conn.), docetaxel (e.g. Taxotere®,from Aventis S. A. of Frankfurt, Germany) methotrexate, azathioprine,vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride (e.g.Adriamycin® from Pharmacia & Upjohn of Peapack N.J.), and mitomycin(e.g. Mutamycin® from Bristol-Myers Squibb). Examples of suchantiplatelets, anticoagulants, antifibrin, and antithrombins includesodium heparin, low molecular weight heparins, heparinoids, hirudin,argatroban, forskolin, vapiprost, prostacyclin and prostacyclinanalogues, dextran, D-phe-pro-arg-chloromethylketone (syntheticantithrombin), dipyridamole, glycoprotein Hh/IIIa platelet membranereceptor antagonist antibody, recombinant hirudin, and thrombininhibitors such as Angiomax™ (Biogen, Inc. of Cambridge, Mass.).Examples of such cytostatic or antiproliferative agents includeangiopeptin, angiotensin converting enzyme inhibitors such as captopril(e.g. Capoten® and Capozide® from Bristol-Myers Squibb), cilazapril orHsinopril (e.g. Prinivil® and Prinzide® from Merck & Co., Inc. ofWhitehouse Station, N.J.); calcium channel blockers (such asnifedipine), colchicine, fibroblast growth factor (FGF) antagonists,fish oil (omega 3-fatty acid), histamine antagonists, lovastatin (aninhibitor of HMG-CoA reductase, a cholesterol lowering drug, brand nameMevacor® from Merck & Co.), monoclonal antibodies (such as thosespecific for Platelet-Derived Growth Factor (PDGF) receptors),nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors,suramin, serotonin blockers, steroids, thioprotease inhibitors,triazolopyrimidine (a PDGF antagonist), and nitric oxide. An example ofan antiallergic agent is permirolast potassium. Other therapeuticsubstances or agents which jtnay be appropriate includealpha-interferon, genetically engineered epithelial cells, tacrolimus,dexamethasone, and rapamycin and structural derivatives or functionalanalogs thereof, such as 40-O-(2-hydroxy)ethyl-rapamycin (known by thetrade name of EVEROLIMUS available from Novartis of New York, N. Y.),40-O-(3-hydroxyl)propyl-rapamycin,40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin, and40-O-tetrazole-rapamycin.

Other polymers that may be suitable for use in some embodiments, forexample other grades of PEEK, such as 30% glass-filled or 30% carbonfilled, provided such materials are cleared for use in implantabledevices by the FDA, or other regulatory body. The use of glass filledPEEK would be desirable where there was a need to reduce the expansionrate and increase the flexural modulus of PEEK for the instrument.Glass-filled PEEK is known to be ideal for improved strength, stiffness,or stability while carbon filled PEEK is known to enhance thecompressive strength and stiffness of PEEK and lower its expansion rate.Still other suitable biocompatible thermoplastic or thermoplasticpolycondensate materials may be suitable, including materials that havegood memory, are flexible, and/or deflectable have very low moistureabsorption, and good wear and/or abrasion resistance, can be usedwithout departing from the scope of the invention. These includepolyetherketoneketone (PEKK), polyetherketone (PEK),polyetherketoneetherketoneketone (PEKEKK), andpolyetheretherketoneketone (PEEKK), and generally apolyaryletheretherketone. Further other polyketones can be used as wellas other thermoplastics. Reference to appropriate polymers that can beused in the tools or tool components can be made to the followingdocuments, all of which are incorporated herein by reference. Thesedocuments include: PCT Publication WO 02/02158 A1, to VictrexManufacturing Ltd. entitled Bio-Compatible Polymeric Materials; PCTPublication WO 02/00275 A1, to Victrex Manufacturing Ltd. entitledBio-Compatible Polymeric Materials; and PCT Publication WO 02/00270 A1,to Victrex Manufacturing Ltd. entitled Bio-Compatible PolymericMaterials. Still other materials such as Bionate®, polycarbonateurethane, available from the Polymer Technology Group, Berkeley, Calif.,may also be appropriate because of the good oxidative stability,biocompatibility, mechanical strength and abrasion resistance. Otherthermoplastic materials and other high molecular weight polymers can beused as well for portions of the instrument that are desired to beradiolucent.

The implant described herein can be made of a metallic material or analloy such as, but not limited to, cobalt-chromium alloys (e.g.,ELGILOY), stainless steel (316L), “MP35N,” “MP20N,” ELASTINITE(Nitinol), tantalum, tantalum-based alloys, nickel-titanium alloy,platinum, platinum-based alloys such as, e.g., platinum-iridium alloy,iridium, gold, magnesium, titanium, titanium-based alloys,zirconium-based alloys, or combinations thereof. Devices made frombioabsorbable or biostable polymers can also be used with theembodiments of the present invention. “MP35N” and “MP20N” are tradenames for alloys of cobalt, nickel, chromium and molybdenum availablefrom Standard Press Steel Co. of Jenkintown, Pa. “MP35N” consists of 35%cobalt, 35% nickel, 20% chromium, and 10% molybdenum. “MP20N” consistsof 50% cobalt, 20% nickel, 20% chromium, and 10% molybdenum.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims presented will define the scope of the inventionand that methods and structures within the scope of these claims andtheir equivalents be covered thereby.

1. A method of treating a patient having a lung with an airway, themethod comprising: deploying a lung implant to the airway of the lung;viewing a deployment position of the deployed lung implant; adjustingthe deployment position of the deployed lung implant to an adjustedposition, and wherein the adjusted position of the deployed lung implantbends the airway of the lung so as to locally compress lung tissue. 2.The method of claim 1, wherein adjusting the deployment position of thedeployed lung implant comprises: coupling a distal end of a recapturedevice to a proximal end of the deployed lung implant; withdrawing atleast the proximal end of the deployed lung implant into a catheter; andstraightening at least a portion of the deployed lung implant.
 3. Themethod of claim 2, wherein the distal end of the recapture devicecomprises forceps for coupling with the proximal end of the deployedlung implant.
 4. The method of claim 2, wherein the distal end of therecapture device comprises a balloon with an inflation port, and whereincoupling the distal end of the recapture device to the proximal end ofthe deployed implant comprises positioning the balloon about theproximal end of the deployed implant, inflating the balloon by pumping afluid into the balloon via the inflation port and wherein the inflatedballoon couples with the proximal end of the deployed implant.
 5. Themethod of claim 2, wherein the deployed lung implant is straightened asthe proximal end of the deployed lung implant is withdrawn into thecatheter.
 6. The method of claim 1, wherein the deployment position ofthe deployed lung implant is viewed from a bronchoscope.
 7. The methodof claim 6, wherein the lung implant is deployed to the airway of thelung through a working channel of the bronchoscope.
 8. The method ofclaim 1, wherein the deployment position of the deployed lung implant isviewed by fluoroscopy.
 9. A method of treating a patient having a lungwith an airway, the method comprising: deploying a lung implant to theairway of the lung, the deployed lung implant bending the airway of thelung so as to locally compress lung tissue; viewing a deploymentposition of the deployed lung implant; removing the deployed lungimplant from the lung.
 10. The method of claim 9, wherein removing thedeployed lung implant from the lung comprises: coupling a distal end ofa recapture device to a proximal end of the deployed lung implant;withdrawing the deployed lung implant into a catheter by pulling theproximal end into the catheter with the recapture device so that thecatheter straightens the deployed lung implant.
 11. The method of claim10, wherein the distal end of the recapture device comprises forceps forcoupling with the proximal end of the deployed lung implant.
 12. Themethod of claim 10, wherein the distal end of the recapture devicecomprises a balloon with an inflation port, and wherein coupling thedistal end of the recapture device to the proximal end of the deployedimplant comprises positioning the balloon about the proximal end of thedeployed implant, inflating the balloon by pumping a fluid into theballoon via the inflation port and wherein the inflated balloon coupleswith the proximal end of the deployed implant.
 13. The method of claim10, wherein the deployed lung implant is straightened as the deployedlung implant is withdrawn into the catheter.
 14. The method of claim 9,wherein the deployment position of the deployed lung implant is viewedfrom a bronchoscope.
 15. The method of claim 14, wherein the lungimplant is withdrawn from the airway of the lung through a workingchannel of the bronchoscope.
 16. The method of claim 9, wherein thedeployment position of the deployed lung implant is viewed byfluoroscopy.